Issues Arising From Study Need Examination

Dear Editor,
JUSTIFICATION FOR THE USE OF STATINS IN PRIMARY PREVENTION – re: the JUPITER Study report — (IMT, Issue 21.11.08) – has not been established in the Jupiter study, despite the reported claims of benefit by the study spokespersons.
The dual purposes of SAFETY determination and long term EFFICACY have not been satisfied in this study.
Several pertinent issues arising from the trial data support this contention and deserve attention accordingly.

1. The poor compliance of the participants, with 25% no longer taking their pills at 1.9 years in the study, raises questions about projected compliance rates, had the trial continued to 4 years as planned, and thereby producing an inconclusive result.

2. Furthermore, the reasons for poor compliance were not reported, suggestive of unreported side-effects which would influence estimates of drug safety over an extended period of time. Details of cardiovascular deaths were not divulged.

3. The “magnitude” of risk reduction, as quoted by Dr. Steve Nissen, looks less impressive when the absolute risk reduction of 0.9% is considered, instead of the artificially inflated figures represented by relative risk reduction figures of almost 50%. Absolute benefits of treatment must be large enough to justify associated risks and costs. This was not the case!

4. Assessments of benefit based on data are invalidated by the premature termination of the study and extrapolation of such data for clinical application is therefore not possible.

5. The value of CRP reduction was not established since, as a risk marker, it was not tested against an alternative risk marker, nor against subjects with CRP levels less than 2.0 mg./L. A 2×2 factorial design using high CRP and normal LDL-C, and normal CRP and normal LDL-C would have better served this purpose. The extravagant conclusions about CRP reduction are therefore not valid.

6. The multiplicity of cardiovascular risk factors invalidates the singular use of CRP to quantify risk and mitigates against arguments for an expanded use of statins aimed at CRP reduction in otherwise “healthy” persons. (It has also been shown that vitamin C reduces CRP).

While JUPITER reveals interesting data, much of which is not new, it does not serve to justify its end goal, which is the expanded use of statin “chemotherapy” in low risk persons.